Management system for point of care testing

ABSTRACT

The present invention relates to a method and system for quality compliance, system and operator verification, and process management for point of care biological sample testing systems used in hospitals and other medical delivery environments. Specifically, the present invention may be directed to a computing device configured to generate a plurality of attributes configured to assess a competency level of an operator to operate at least one sample testing instrument, obtain operator derived data pertaining to the operator&#39;s ability to operate the at least one sample testing instrument, and determine a competency level of the operator for the at least one sample testing instrument based the plurality of attributes and the operator derived data.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.61/789,675 filed on Mar. 15, 2013, the entirety of which is incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates to a method and system for qualitycompliance, system and operator verification, and process management forpoint of care biological sample testing systems used in hospitals andother medical delivery environments. Specifically, the present inventionrelates to portable blood testing instrumentation that works inconjunction with consumable cartridges and how this is efficientlyachieved in a modern regulatory environment.

BACKGROUND OF THE INVENTION

For hospitals, the introduction of point-of-care testing capabilitieshas created unique requirements and issues for quality compliance,system and operator verification, and process management. These issuesarise from the use of a plurality of instruments running multiple typesof disposable sample testing devices at various locations within ahospital. Consequently, a hospital must provide an adequate supply ofeach type of device at each site of use, while ensuring the devices arewithin their usable shelf-life, along with also ensuring that theinstruments are performing to specification. A further consideration isensuring that each user of the technology, or operator, is properlyqualified to do so and maintains a valid training record.

Point-of-care sample analysis systems are generally based on a re-usablereading apparatus that performs sample tests using a single-usedisposable device, e.g., a cartridge or strip that contains analyticalelements, e.g., electrodes or optics for sensing analytes such as pH,oxygen and glucose. The disposable device can include fluidic elements(e.g., conduits for receiving and delivering the sample to sensingelectrodes or optics), calibrant elements (e.g., aqueous fluids forstandardizing the electrodes with a known concentration of analyte), anddyes with known extinction coefficients for standardizing optics. Thereading apparatus or instrument contains electrical circuitry and othercomponents for operating the electrodes or optics, making measurements,and doing computations. The reading apparatus also has the ability todisplay results and communicate those results to laboratory and hospitalinformation systems (LIS and HIS, respectively), for example, via acomputer workstation or other data management system. Communicationbetween the reading apparatus and a workstation, and between theworkstation and a LIS, can be via, for example, an infrared link, awired connection, wireless communication, or any other form of datacommunication that is capable of transmitting and receiving electricalinformation, or any combination thereof. A notable point-of-care system(The i-STAT® System, Abbott Point of Care Inc., Princeton, N.J.) isdisclosed in U.S. Pat. No. 5,096,669, which comprises a disposabledevice, operating in conjunction with a hand-held analyzer, forperforming a variety of measurements on blood or other fluids.

One benefit of point-of-care sample testing systems is the eliminationof the time-consuming need to send a sample to a central laboratory fortesting. Point-of-care sample testing systems allow a nurse or doctor(user or operator), at the bedside of a patient, to obtain a reliablequantitative analytical result, comparable in quality to that whichwould be obtained in a laboratory. In operation, the nurse selects adevice with the required panel of tests, draws a biological sample fromthe patient, dispenses it into the device, optionally seals the device,and inserts the device into the reading apparatus. While the particularorder in which the steps occur may vary between different point-of-caresystems and providers, the intent of providing rapid sample test resultsclose to the location of the patient remains. The reading apparatus thenperforms a test cycle, i.e., all the other analytical steps required toperform the tests. Such simplicity gives the doctor quicker insight intoa patient's physiological status and, by reducing the time for diagnosisor monitoring, enables a quicker decision by the doctor on theappropriate treatment, thus enhancing the likelihood of a successfulpatient outcome.

In the emergency room and other acute-care locations within a hospital,the types of sample tests required for individual patients tend to vary.Thus, point-of-care systems generally offer a range of disposabledevices with different sample tests, or combinations of tests. Forexample, for blood analysis devices, in addition to traditional bloodtests, including oxygen, carbon dioxide, pH, potassium, sodium,chloride, hematocrit, glucose, urea, creatinine and calcium, other testscan include, for example, prothrombin time (PT), activated clotting time(ACT), activated partial thromboplastin time (APTT), cardiac troponin I(cTnI), brain natriuretic peptide (BNP), creatine kinase MB (CKMB) andlactate. While devices typically contain between one and ten tests, itshould be appreciated by persons of ordinary skill in the art that anynumber of tests may be contained on a device. For example, a device forgenetic screening may include numerous tests. To illustrate the need fordifferent devices, a patient suspected of arrhythmia may require adevice with a test combination that includes a potassium test, whereas apatient suspected of a diabetic hypoglycemia may require a device with atest combination that includes a glucose test. An emergency room willneed to have sufficient inventory of both types of device to meet theanticipated workload.

Quality compliance, system verification and process management at thepoint-of-care has traditionally relied on direct human intervention.Typically, a person from the hospital central laboratory, e.g., adesignated point-of-care testing coordinator, would be responsible forregularly visiting point-of-care testing locations to track performance.Because of the substantially manual nature of this approach, there areseveral opportunities for delay and possible human error. The presentinvention seeks to ameliorate these problems and provide a substantiallyautomated system for quality compliance, operator and systemverification, and process management.

SUMMARY OF THE INVENTION

In one embodiment, the present invention may be directed to a methodimplemented in a computer infrastructure having computer executable codetangibly embodied on a computer readable storage medium havingprogramming instructions operable to generate a plurality of attributesconfigured to assess a competency level of an operator to operate atleast one sample testing instrument and set a compliance threshold forthe at least one sample testing instrument. The programming instructionsmay be further operable to obtain operator derived data pertaining tothe operator's ability to operate the at least one sample testinginstrument. The operator derived data may comprise at least twoattribute test results obtained by the operator. The programminginstructions may be further operable to determine a compliance status ofthe operator for the plurality of attributes based on the obtainedoperator derived data, and determine the competency level of theoperator for the at least one sample testing instrument based on acomparison of the compliance status of the operator to the setcompliance threshold. The programming instructions may be furtheroperable to communicate the competency level of the operator to the atleast one sample testing instrument.

In some aspects, the generating the plurality of attributes may compriseselecting at least two attributes from the group consisting of: aknowledge test for operation of the at least one instrument, a knowledgetest for biological sample acquisition and disposition with the at leastone instrument, a knowledge test on biological sample testingregulations, a practical test on obtaining biological sample testresults with the at least one instrument, a practical test on qualitycontrol testing with the at least one instrument, a practical test ondata entry, and data handling with the at least one instrument.

In some embodiments, each attribute of the plurality of attributes maycomprise an electronic signature element, and the determining thecompliance status of the operator may further comprises determiningwhether the electronic signature element for each attribute is completedby an authorized user.

In addition, optionally the set compliance threshold may comprise anycombination of at least two attributes having an approved compliancestatus, and the determining the competency level may comprise that whenthe compliance status includes at least two attributes having anapproved compliance status, determining the competency level to becompliant, and when the compliance status includes less than twoattributes having an approved compliance status, determining thecompetency level to be non-compliant.

In another embodiment, a method of deploying a system for assessingcompetency of an operator to operate at least one sample testinginstrument may be provided. The method may comprise providing a computerinfrastructure, being operable to generate a plurality of attributesconfigured to assess the competency of the operator to operate the atleast one sample testing instrument, set a compliance threshold for eachattribute of the plurality of attributes, set an overall compliancethreshold for the at least one sample testing instrument, and obtainoperator derived data pertaining to the operator's ability to operatethe at least one sample testing instrument. The computer infrastructuremay be further operable to compare the operator derived data to the setcompliance threshold for each attribute of the plurality of attributes,determine a compliance status of the operator for each attribute basedon the comparison of the operator derived data to the set compliancethresholds, generate an overall compliance status of the operator basedon the determined compliance status of the operator for each attribute,and compare the overall compliance status of the operator to the setoverall compliance threshold for the at least one sample testinginstrument. The computer infrastructure may be further operable todetermine a competency level of the operator for the at least one sampletesting instrument based on the comparison of the overall compliancestatus of the operator to the set overall compliance threshold, andcommunicate the competency level of the operator to the at least onesample testing instrument.

In another embodiment, a method of deploying a system for compliancemonitoring may be provided. The method may comprise providing a computerinfrastructure being operable to generate a plurality of attributesconfigured to assess a competency of an operator to operate at least onesample testing instrument, set an overall compliance threshold for theat least one sample testing instrument, and obtain operator derived datapertaining to the operator's ability to operate the at least one sampletesting instrument. The operator derived data may comprise at least twoattribute test results obtained by the operator, and a correspondingoperator identifier configured to identify the operator. The computerinfrastructure may be further operable to determine a compliance statusof the operator for the plurality of attributes based on the obtainedoperator derived data, determine a competency level of the operator forthe at least one sample testing instrument based on a comparison of thecompliance status of the operator to the set overall compliancethreshold, and communicate the competency level of the operator to theat least one sample testing instrument. The method may further compriseproviding the at least one sample testing instrument being operable toreceive input including the operator identifier configured to identifythe operator, analyze the biological sample, determine at least one testresult, communicate the at least one test result to the computerinfrastructure, receive the competency level of the operator, and lockthe user from operating the at least one sample testing instrument whenthe competency level is non-compliant.

In another embodiment, a system may be provided implemented in hardwareand comprising a tracking module configured to generate a plurality ofattributes configured to assess a competency level of an operator tooperate at least one sample testing instrument and set a compliancethreshold for the at least one sample testing instrument. The trackingmodule may be further configured to obtain operator derived datapertaining to the operator's ability to operate the at least one sampletesting instrument. The operator derived data may comprise at least twoattribute test results obtained by the operator. The tracking module maybe further configured to determine a compliance status of the operatorfor the plurality of attributes based on the obtained operator deriveddata, determine the competency level of the operator for the at leastone sample testing instrument based on a comparison of the compliancestatus of the operator to the set compliance threshold, and communicatethe competency level of the operator to the at least one sample testinginstrument.

In addition, optionally the at least two attribute test results may belinked to a corresponding operator identifier configured to identify theoperator, and the step of obtaining the operator derived data maycomprise receiving the at least two test attribute results and theoperator identifier.

In some embodiments, the set compliance threshold may comprise anycombination of at least two attributes having an approved compliancestatus, and the step of determining the competency level may comprisedetermining the competency level to be compliant when the compliancestatus includes at least two attributes having an approved compliancestatus, and determining the competency level to be non-compliant whenthe compliance status includes less than two attributes having anapproved compliance status.

In another embodiment, a system may be provided implemented in hardwarecomprising at least one sample testing instrument configured to receiveinput including an operator identifier configured to identify anoperator of the at least one sample testing instrument, analyze abiological sample, determine at least one test result for the biologicalsample, and communicate the at least one test result. The system mayalso comprise a tracking module configured to generate a plurality ofattributes configured to assess a competency level of the operator tooperate the at least one sample testing instrument, set a compliancethreshold for the at least one sample testing instrument, and obtainoperator derived data pertaining to the operator's ability to operatethe at least one sample testing instrument. The operator derived datamay comprise the at least one test result communicated by the at leastone sample testing instrument. The tracking module may also beconfigured to determine a compliance status of the operator for theplurality of attributes based on the obtained operator derived data,determine the competency level of the operator for the at least onesample testing instrument based on a comparison of the compliance statusof the operator to the set compliance threshold, and communicate thecompetency level of the operator to the at least one sample testinginstrument. The at least one sample testing instrument may be furtherconfigured to receive the competency level of the operator, and lock theoperator from further operating the at least one instrument when thecompetency level is non-compliant.

In another embodiment, the present invention may be directed to computersystem for assessing competency of an operator to operate at least onesample testing instrument. The system may comprise a CPU, a computerreadable memory and a computer readable storage media. The system mayfurther comprise first program instructions to generate a plurality ofattributes configured to assess the competency of the operator tooperate the at least one sample testing instrument, second programinstructions to set a compliance threshold for each attribute of theplurality of attributes, third program instructions to set an overallcompliance threshold for the at least one sample testing instrument,fourth program instructions to obtain operator derived data pertainingto the operator's ability to operate the at least one sample testinginstrument, fifth program instructions to compare the operator deriveddata to the set compliance threshold for each attribute of the pluralityof attributes, sixth program instructions to determine a compliancestatus of the operator for each attribute based on the comparison of theoperator derived data to the set compliance thresholds, seventh programinstructions to generate an overall compliance status of the operatorbased on the determined compliance status of the operator for eachattribute, eighth program instructions to compare the overall compliancestatus of the operator to the set overall compliance threshold for theat least one sample testing instrument, ninth program instructions todetermine a competency level of the operator for the at least one sampletesting instrument based on the comparison of the overall compliancestatus of the operator to the set overall compliance threshold, andtenth program instructions to communicate the competency level of theoperator to the at least one sample testing instrument. The firstthrough tenth program instructions may be stored on the computerreadable storage media for execution by the CPU via the computerreadable memory.

In yet another embodiment, the present invention may be directed tocomputer program product comprising a computer readable storage mediumhaving readable program code embodied in the storage medium. Thecomputer program product may include at least one component operable togenerate a plurality of attributes configured to assess a competencylevel of an operator to operate at least one sample testing instrument,set a compliance threshold for the at least one sample testinginstrument, and obtain operator derived data pertaining to theoperator's ability to operate the at least one sample testinginstrument. The operator derived data comprises at least two attributetest results obtained by the operator. The at least one component may befurther operable to determine a compliance status of the operator forthe plurality of attributes based on the obtained operator derived data,determine the competency level of the operator for the at least onesample testing instrument based on a comparison of the compliance statusof the operator to the set compliance threshold, and communicate thecompetency level of the operator to the at least one sample testinginstrument.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be better understood in view of the followingnon-limiting figures, in which:

FIG. 1 shows an isometric view of a disposable sensing device and readerdevice in accordance with some aspects of the invention;

FIG. 2 shows an exploded view of a cartridge in accordance with someaspects of the invention;

FIG. 3 is an illustrative external environment for implementing theinvention in accordance with some aspects of the invention;

FIG. 4 is a block diagram illustrating an operator compliance monitoringsystem for a point-of-care diagnostic technology, in accordance withsome aspects of the invention; and

FIGS. 5 and 6 are illustrative process flow diagrams for implementingthe system in accordance with some aspects of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Introduction

A typical point of care testing program in an institution may have tensor hundreds of non-laboratory operators with wide ranges of education,training, responsibilities, and understanding of medical conditions andthe indications and implications of medical testing. A challenge of anyprogram for quality compliance is the initial training of the operatorsand the ongoing assessment of their testing competency. Typically, thisis a responsibility of a quality compliance manager in partnership withnursing and other clinical personnel, who manually construct andimplement a meaningful competency assessment process.

The present invention is directed to providing a computing toolconfigured to help quality compliance managers to efficiently andeffectively construct, implement, and maintain a meaningful competencyassessment process. Competency assessment may include the evaluation ofan individual's knowledge, skills, and correct practice of requiredprocesses and procedures. Typically, competency assessment programsinclude evaluating the competency of all testing personnel and assuringthat the staff maintains their competency to perform test procedures andreport result promptly, accurately, and proficiently.

Some embodiments of the present invention are directed to utilizing thecomputing tool to develop a competency assessment program that includesa plurality of attributes configured to assess a competency level of atleast one operator to operate at least one sample testing instrument. Inaccordance with these aspects of the present invention, the plurality ofattributes may be constructed to provide an evaluation of an operator'sknowledge, skills, and correct practice of required processes andprocedures with respect to the at least one sample testing instrument.For example, the plurality of attributes may include procedures forassessing competency as mandated by the Clinical Laboratory ImprovementAct. More specifically, in some embodiments, the plurality of attributesmay include methods for assessing competency including directobservation of routine patient test performance, including testingperformance and monitoring the recording of the results (e.g., this mayinclude recording all test results performed by the operator on a sampletesting instrument and monitoring the results for any instrumentreported errors). The plurality of attributes may also include thereview of intermediate test results, quality control results,proficiency testing results, and preventive maintenance records (e.g.,this may include recording all of these results performed by theoperator and monitoring the results for inaccuracies). The plurality ofattributes may also include observation of performance of instrumentmaintenance and function checks (e.g., this may include recording theresults of knowledge tests for operation of the at least oneinstrument). The plurality of attributes may also include the assessmentof problem solving skills (e.g., this may include recording the resultsof knowledge tests for biological sample acquisition and dispositionwith the at least one instrument and knowledge tests on biologicalsample testing regulations). Although the plurality of attributes aredescribed herein with respect to the above-mentioned examples, it shouldbe understood by those of ordinary skill in the art that such examplesare non-limiting, and the attributes may be designed in any manner solong as they are configured to provide procedures for assessingcompetency of an operator operating a sample testing instrument inaccordance with the various aspects of the present invention.

A central data management system that comprises the computing tool maybe configured to automatically keep track of the plurality of attributesand compliance thresholds (e.g., a means for evaluating compliance ornon-compliance with operation of the sample testing instruments)associated with each sample testing instrument within the testingprogram. In some embodiments, the central data management system mayalso keep track of records for each operator within the testing programusing an operator tracking record and/or profile system.

The records may include each operator's competency level for sampletesting instruments, results of knowledge tests, analytical testresults, clinical control results, proficiency test results, etc. Itshould be understood by those of ordinary skill in the art that theknowledge test or knowledge test results may pertain to written ortraining proficiency tests that provide an evaluation of an operator'sknowledge of a certain aspect of diagnostic testing involving the sampletesting instrument (e.g., a knowledge test for biological sampleacquisition and disposition with the instrument); the analytical test oranalytical test results may pertain to clinical diagnostic tests run ona sample (e.g., a blood sample from a patient) using the sample testinginstrument; the control tests or control test results may pertain toquality control measures designed to minimize the effects of variablesduring the clinical diagnostic tests (e.g., running a control samplehaving a known analyte concentration using the sample testinginstrument); and the proficiency tests or proficiency test results maypertain to testing previously analyzed specimens with knownconcentrations of analyte, internal blind testing samples, or externalproficiency testing samples configured for statistical quality assuranceprograms that enable laboratories to assess their performance inconducting test methods.

In various embodiments, the central data management system may befurther configured to determine the competency level of the operator forsample testing instruments using the plurality of attributes andcompliance thresholds, and automatically convey the competency level ofthe operator to the sample testing instruments. In additionalembodiments, the sample testing instruments may be configured to lockthe user from operating the sample testing instruments in the instancethat the operator has been determine to be non-compliant with theplurality of attributes developed by the quality compliance manager.

Advantageously, the present invention is able to provide a point of carequality system that consistently implements the competency assessmentplan, and provides an electronic means for tracking and documentingcompetency assessment records to assist in implementing the plan. Evenmore advantageously, the present invention is able to provide a point ofcare quality system that ensures employees perform critical tasksaccurately by locking non-compliant employees out from performing suchcritical tasks (e.g., operating sample testing instruments).

Biological Sample Test System

The present invention relates to a handheld In-Vitro Diagnostic (IVD)instrument system including a self-contained disposable sensing deviceor cartridge and a reader or analyzer configured for use at a patientbedside. A fluid sample to be measured is drawn into a sample entryorifice or port in the cartridge and the cartridge is inserted into theanalyzer through a slotted opening or port. Measurements performed bythe analyzer are output to a display or other output device, such as aprinter or data management system via a port on the analyzer to acomputer port. Transmission can be via Wifi, Bluetooth link, infraredand the like. For example, the handheld IVD instrument system may be ofsimilar design to the systems disclosed in U.S. Pat. No. 5,096,669 andU.S. Pat. No. 7,419,821, both of which are incorporated herein byreference in their entireties.

More specifically, a system and method are disclosed for operating aplurality of point-of-care diagnostic devices (e.g., cartridges). Eachdevice may be configured to perform at least one biological sampleanalysis, e.g., blood, plasma, urine tests and the like, and each devicemay have a usable lifetime. FIG. 1 shows the component parts andinteractions of a typical point-of-care system. The system 100 mayinclude a reading apparatus 102, a disposable device 103, a central datastation or data manager 104 and a box of devices 105. The readingapparatus 102 may include, for example, a display 106, electronic memoryand a keypad 107 for manual data entry. The disposable device 103 mayinclude, for example, a port 108 for receiving a patient sample, and thedevice 103 may be inserted into the reading apparatus 102 through aslotted opening 109. The reading apparatus 102 may communicate with thecentral data manager 104 using, for example, a wireless connection, aninfrared link, an optical link, a network connection 110, 111, or anyother form of communication link that uses any form of communicationprotocol to transfer information.

The reading apparatus 102 may include a barcode reader for readinginformation from a patient's bar-coded wristband, from a barcode on adevice 103 or from any other item (e.g., the box of devices 105, box ofcontrol fluids, etc.) used in conjunction with the reading apparatus102. Other such encoding arrangements can be used. For example, thereading apparatus 102 may also include (either alternatively or inaddition to the barcode reader) a radio-frequency (RF) identificationdevice that is capable of identifying a RF tag that is contained on orin each individual device or each box of devices 108. According toanother exemplary embodiment of the present invention, one or more ofthe encoding arrangements may be based upon a binary coding pin array ofthe type disclosed in, for example, U.S. Pat. No. 4,954,087, which isincorporated herein by reference in its entirety.

The various encoding arrangements may convey relevant information suchas, for example, the identity of a specific device type, date andlocation of manufacture, manufacturing lot number, expiration date, aunique number associated with a device, coefficients for use by thereading apparatus 102 associated with the calculation of blood or othersample parameters and the like. The devices may be used for measurementsselected from groups such as, for example, amperometric, potentiometric,conductimetric, optical and the like. Other relevant information of thisgeneral type is well known in the medical manufacturing art, as is thetechnology for bar coding and barcode recognition.

Other information encoded with the device may include the refrigeratorshelf life, the ambient temperature shelf life, the age of the deviceand the like. Alternatively, rather than including numerous elements ofrelevant information, a single piece of information, e.g., a lot number,may be included. The lot number may be any alphanumeric sequence orunique identifier that can be used to identify the device 104 andassociate relevant information with that device. For example, the lotnumber can be applied to a lookup table or any other type of computerdatabase located within or connected to the reading apparatus 102 or anyother computing system, e.g., the data manager 104. Using the lookuptable or computer database, relevant shelf life or other suchinformation can be associated with the lot number such that, based onthe lot number, the refrigerator shelf life, the ambient temperatureshelf life, the age of the device 103 and the like can be determined.

The devices 103 may have a finite refrigerator and ambient temperatureshelf life. For example, the devices 103 may have a refrigerated usablelifetime in the range of, for example, about three months to threeyears, although the devices 103 could have any range of refrigeratedusable lifetime. The devices 103 may have an ambient temperature usablelifetime in the range of, for example, about three days to three months,although the devices 103 can have any range of ambient temperatureusable lifetime. Given that the devices 103 may have a finiterefrigerator and ambient temperature shelf life, there may be a need toensure that expired devices 103 (e.g., the devices 103 that haveexceeded the refrigerated or ambient temperature shelf life) are notused.

Referring to the disposable device 103 and the patient sample entry port108, the device 103 may perform analyses on a range of biological sampletypes. These sample types may include, for example, blood, plasma,serum, sputum, cerebrospinal fluid, tears, urine, body tissue, and fecalmatter and the like. Appropriate consumable items for use in conjunctionwith the device 103 are well known in the art. These include, forexample, vacutainers, needles, capillary tubes and collection devices,control fluids of different types, syringes, swabs, printer paper,batteries and any other consumable item that can be used in conjunctionwith the device 103. The consumable items can also be used to facilitateintroduction of the sample into the sample entry port 108.

The reading apparatus 102 may include a microprocessor (e.g., any typeof processor). The reading apparatus may also include any type ofcomputer memory or any other type of electronic storage medium that islocated either internally or externally to the reading apparatus 102,such as, for example, a random access memory (RAM). According toexemplary embodiments, the RAM may contain, for example, the operatingprogram for the reading apparatus 102. As will be appreciated based onthe following description, the RAM can, for example, be programmed usingconventional techniques known to those having ordinary skill in the artof computer programming. The actual source code or object code forcarrying out the steps of, for example, a computer program can be storedin the RAM.

The reading apparatus 102 may include a communications port (e.g., anytype of communications port through which electronic information can becommunicated over a communications connection, whether locally orremotely) with which the reading apparatus 102 can communicate with, forexample, the data manager 104. The reading apparatus 102 may alsoinclude the input port 109 that, for example, allows insertion of thedevice 103 and is appropriately configured to receive the device 103.The reading apparatus 102 may also include a user interface. The userinterface may be any type of computer monitor or display device on whichgraphical and/or textual information can be displayed to a user (e.g.,through a graphical user interface) and which allows a user to enterinformation (e.g., commands and the like) through, for example, akeyboard, a touch-screen, any type of pointing device, electronic pen,and the like. For example, the user interface can be configured toreceive instructions from the operator of the reading apparatus 102. Itshould also be appreciated that, while a single reading apparatus 102 isdescribed above, multiple reading apparatus 102 can be included within asystem where each is connected to the data manager 104. Typically, eachdepartment within a hospital may have one or more readers.

It should further be appreciated by persons of ordinary skill in the artthat the devices 103, may in fact be a plurality with each type capableof being used for a different test. The devices 103 can include, forexample, blood analysis devices, urine analysis devices, serum analysisdevices, plasma analysis devices, saliva analysis devices, cheek swabanalysis devices, or any other type of disposable diagnostic device thatcan be used for point-of-care sample testing.

The data manager 104 may be configured to provide connectivity betweenindividual reading apparatus 102 and central locations, such as, forexample, a LIS or HIS, and device 103. The data manager 104 may beconnected with the various system constituents using any type ofcommunications connection that is capable of transmitting and receivingelectronic information, such as, for example, an Ethernet connection orother computer network connection. The data manager 104 can alsooptionally provide a direct link back to a vendor's information system,for example via the Internet, a dial-up connection or other direct orindirect communication link, or through the LIS or HIS. Such anexemplary embodiment can provide for automated re-ordering of devices103 to maintain the predetermined levels of inventory at a hospital andallow the vendor to forecast demand and adequately plan the manufactureof the devices 103.

Exemplary Device or Cartridge

FIG. 2 shows an exploded view of cartridge 120 as described U.S. PatentApplication Publication No. 2011/0150705 and U.S. patent applicationSer. No. 13/530,501. The cartridge 120 comprises a sample entry port125, at least one sensor 130 (e.g., an electrochemical sensor, animmunosensor, a hematocrit sensor, a conductivity sensor, etc.), and apouch 135 containing a fluid, e.g., a sensor-standardization,calibration fluid, and/or wash fluid. The at least one sensor 130 may besubstantially aligned to a plane parallel to a horizontal plane of thebase of the analyzer. A recessed region 140 of the cartridge 120preferably includes a spike 145 configured to rupture the pouch 135,upon application of a force upon the pouch 135, for example, by theanalyzer 102 (shown in FIG. 1). Once the pouch 135 is ruptured, thesystem is configured to deliver the fluid contents from the pouch 135into a conduit 150. Movement of the fluid into and through the conduit150 and to a sensor region 155 (e.g., a conduit comprising the at leastone sensor 130 and a sensing reagent for the sensor) may be effected bya pump, e.g., a pneumatic pump connected to the conduit 150. Preferably,the pneumatic pump comprises a displaceable membrane 160. In theembodiment shown in FIG. 2, the cartridge 120 or test device may beconfigured to pump fluid via the displaceable membrane 160 from theruptured pouch 135 and the sample entry port 125 through the conduit 150and over the sensor region 155. The at least one sensor 130 generateselectric signals based on a concentration of specific chemical speciesin the sample, e.g., performs an immunoassay on a blood sample from apatient.

The analytes/properties to which the at least one sensor respondsgenerally may be selected from among hematocrit, troponin, CKMB, BNP,beta human chorionic gonadotropin (bHCG), carbon dioxide partialpressure (pCO₂), partial pressure oxygen (pO₂), pH, PT, ACT, activatedpartial thromboplastin time (APTT), sodium, potassium, chloride,calcium, urea, glucose, creatinine, lactate, oxygen, and carbon dioxide,thyroid stimulating hormone, parathyroid hormone, D-dimer, prostatespecific antibody and the like, and combinations thereof. Preferably,the analyte is tested in a liquid sample that is whole blood, howeverother samples can be used including blood, plasma, serum, sputum,cerebrospinal fluid, tears, urine, body tissue, and fecal matter andamended forms thereof. Amendments can include diluents and reagents suchas anticoagulants and the like.

System Environment

As will be appreciated by one skilled in the art, aspects of the presentinvention may be embodied as a system, method or computer programproduct. Accordingly, aspects of the present invention may take the formof an entirely hardware embodiment, an entirely software embodiment(including firmware, resident software, micro-code, etc.) or anembodiment combining software and hardware aspects that may allgenerally be referred to herein as a “circuit,” “module” or “system.”Furthermore, aspects of the present invention may take the form of acomputer program product embodied in one or more computer readablemedium(s) having computer readable program code embodied thereon.

Any combination of one or more computer readable medium(s) may beutilized. The computer readable medium may be a computer readable signalmedium or a computer readable storage medium. A computer readablestorage medium may be, for example, but not limited to, an electronic,magnetic, optical, electromagnetic, infrared, or semiconductor system,apparatus, or device, or any suitable combination of the foregoing. Morespecific examples (a non-exhaustive list) of the computer readablestorage medium would include the following: an electrical connectionhaving one or more wires, a portable computer diskette, a hard disk,RAM, a read-only memory (ROM), an erasable programmable read-only memory(EPROM or Flash memory), an optical fiber, a portable compact discread-only memory (CD-ROM), an optical storage device, a magnetic storagedevice, or any suitable combination of the foregoing. In the context ofthis document, a computer readable storage medium may be any tangiblemedium that can contain, or store a program for use by or in connectionwith an instruction execution system, apparatus, or device.

A computer readable signal medium may include a propagated data signalwith computer readable program code embodied therein, for example, inbaseband or as part of a carrier wave. Such a propagated signal may takeany of a variety of forms, including, but not limited to,electro-magnetic, optical, or any suitable combination thereof. Acomputer readable signal medium may be any computer readable medium thatis not a computer readable storage medium and that can communicate,propagate, or transport a program for use by or in connection with aninstruction execution system, apparatus, or device.

Program code embodied on a computer readable medium may be transmittedusing any appropriate medium, including but not limited to wireless,wireline, optical fiber cable, RF, etc., or any suitable combination ofthe foregoing.

Computer program code for carrying out operations for aspects of thepresent invention may be written in any combination of one or moreprogramming languages, including an object oriented programming languagesuch as Java, Smalltalk, C++ or the like and conventional proceduralprogramming languages, such as the “C” programming language or similarprogramming languages. The program code may execute entirely on theuser's computer, partly on the user's computer, as a stand-alonesoftware package, partly on the user's computer and partly on a remotecomputer or entirely on the remote computer or server. In the latterscenario, the remote computer may be connected to the user's computerthrough any type of network, including a local area network (LAN) or awide area network (WAN), or the connection may be made to an externalcomputer (for example, through the Internet using an Internet ServiceProvider).

Aspects of the present invention are described below with reference toflowchart illustrations and/or block diagrams of methods, apparatus(systems) and computer program products according to embodiments of theinvention. It will be understood that each block of the flowchartillustrations and/or block diagrams, and combinations of blocks in theflowchart illustrations and/or block diagrams, can be implemented bycomputer program instructions. These computer program instructions maybe provided to a processor of a general purpose computer, specialpurpose computer, or other programmable data processing apparatus toproduce a machine, such that the instructions, which execute via theprocessor of the computer or other programmable data processingapparatus, create means for implementing the functions/acts specified inthe flowchart and/or block diagram block or blocks.

These computer program instructions may also be stored in a computerreadable medium that can direct a computer, other programmable dataprocessing apparatus, or other devices to function in a particularmanner, such that the instructions stored in the computer readablemedium produce an article of manufacture including instructions whichimplement the function/act specified in the flowchart and/or blockdiagram block or blocks.

The computer program instructions may also be loaded onto a computer,other programmable data processing apparatus, or other devices to causea series of operational steps to be performed on the computer, otherprogrammable apparatus or other devices to produce a computerimplemented process such that the instructions which execute on thecomputer or other programmable apparatus provide processes forimplementing the functions/acts specified in the flowchart and/or blockdiagram block or blocks.

FIG. 3 shows an illustrative environment 200 for managing the processesin accordance with the invention. To this extent, the environment 200includes a server or other computing system 212 that can perform theprocesses described herein. In particular, the server 212 includes acomputing device 214 (e.g., the data manager 104). The computing device214 can be resident on a network infrastructure or computing device of athird party service provider (any of which is generally represented inFIG. 3).

The computing device 214 also includes a processor 220, memory 222A, anI/O interface 224, and a bus 226. The memory 222A can include localmemory employed during actual execution of program code, bulk storage,and cache memories which provide temporary storage of at least someprogram code in order to reduce the number of times code must beretrieved from bulk storage during execution. In addition, the computingdevice 214 includes RAM, ROM, and an operating system (O/S).

The computing device 214 may be in communication with an external I/Odevice/resource 228 and the storage system 222B. For example, the I/Odevice 228 can comprise any device that enables an individual tointeract with the computing device 214 or any device that enables thecomputing device 214 to communicate with one or more other computingdevices using any type of communications link. The external I/Odevice/resource 228 may be for example, a handheld device, PDA, handset,mechanical keyboard, etc.

In general, the processor 220 executes computer program code (e.g.,program control 244), which can be stored in the memory 222A and/orstorage system 222B. Moreover, in accordance with aspects of theinvention, the program control 244 may communicate with a managementmodule 250, tracking module 260, the reading apparatus 102, and or otherremote devices 270 such as operator's personal computer or mobiledevice. The management module 250 and tracking module 260 can beimplemented as one or more program code in the program control 244stored in memory 222A as separate or combined modules. Additionally, themanagement module 250 and tracking module 260 may be implemented asseparate dedicated processors or a single or several processors toprovide the function of these modules. In embodiments, the managementmodule 250 and tracking module 260 may be configured to carry out theprocesses of the present invention discussed in further detail herein.While executing the computer program code, the processor 220 can readand/or write data to/from memory 222A, storage system 222B, and/or I/Ointerface 224. The program code executes the processes of the invention.The bus 226 provides a communications link between each of thecomponents in the computing device 214.

The computing device 214 can comprise any general purpose computingarticle of manufacture capable of executing computer program codeinstalled thereon (e.g., a personal computer, a smartphone, a laptop, atablet, etc.). However, it is understood that computing device 214 isonly representative of various possible equivalent-computing devicesthat may perform the processes described herein. To this extent, in someembodiments, the functionality provided by computing device 214 can beimplemented by a computing article of manufacture that includes anycombination of general and/or specific purpose hardware and/or computerprogram code. In each embodiment, the program code and hardware can becreated using standard programming and engineering techniques,respectively.

Similarly, computing infrastructure 212 is only illustrative of varioustypes of computer infrastructures for implementing the invention. Forexample, in embodiments, server 212 comprises two or more computingdevices (e.g., a server cluster) that communicate over any type ofcommunications link, such as a network, a shared memory, or the like, toperform the process described herein. Further, while performing theprocesses described herein, one or more computing devices on server 212can communicate with one or more other computing devices external toserver 212 using any type of communications link. The communicationslink can comprise any combination of wired and/or wireless links; anycombination of one or more types of networks (e.g., the Internet, a widearea network, a local area network, a virtual private network, etc.);and/or utilize any combination of transmission techniques and protocols.

Instrument and Cartridge Operator Competency and Compliance MonitoringSystem

FIG. 4 shows an exemplary compliance monitoring system 300 in accordancewith some aspects of the present invention. The compliance monitoringsystem 300 is configured to ensure that an operator is properlyqualified to operate a biological sample testing system (e.g., system100 as discussed with respect to FIG. 1). The operator compliancemonitoring system 300 may be conceived for distributed or point of careanalytical testing with a plurality of portable test instruments (e.g.,sample testing instrument or reading apparatus 102), typically locatedin a medical facility. The compliance monitoring system 300 may comprisea data tracking system 310 with an operator tracking record (e.g.,management module 250 and/or tracking module 260 as discussed withrespect to FIG. 3) and may have a plurality of attributes required forcompliance by the operator when using one or more of the portable testinstruments 102. Specifically, the tracking system 310 may comprise atesting results store 315, which can communicate in a mono-directionalor bi-directional manner with devices internal to the system 300including the portable test instruments 102 and other devices 320external to the system 300 (e.g., external computing devices that couldsend data to the data tracking system 310, such as Knowledge Managementsystems having on-line quiz results, in-service training eventcompletion, etc.). The plurality of attributes for each operator (e.g.,user, nurse, doctor, etc.) in the data tracking system 310 may beselected by a data tracking system manager or quality compliance manager325 (e.g., a supervisor or trainer) and communicated from the compliancemonitoring system 310 to the portable test instruments 102. Incircumstances of compliance by the operator, the compliance monitoringsystem 300 may permit use of at least one of the portable testinstruments 102, whereas non-compliance may automatically lock out theoperator from use of at least one of the instruments 102.

Several other features of the compliance monitoring system may includethat each required attribute have an electronic signature elementoperable by designated super-users, trainers, nurse managers, or systemmanagers, each required attribute may have an electronic loggingelement, and each required attribute may be selected from, for example,a set of competency requirements from the College of AmericanPathologists, such as: Direct observations of routine patient testperformance, including patient preparation, if applicable, specimenhandling, processing and testing; Monitoring the recording and reportingof test results; Review of intermediate test results or worksheets,quality control records, proficiency testing results and preventivemaintenance records; Direct observation of performance of instrumentmaintenance and function checks; Assessment of test performance throughtesting previously analyzed specimens, internal blind testing samples orexternal proficiency testing samples; and Evaluation of problem-solvingskills.

In addition, the required attributes may be updatable by the systemmanager 325, communicated to the instruments 102, and displayed for theoperator. Advantageously, the compliance monitoring system 300 allowsfor automatic tracking of operator compliance for a plurality ofoperators, e.g., as many as a hundred nurses in a single hospital.Furthermore, each portable test instrument 102 may be configured tocommunicate each blood test result and operator identity to the resultsstore 315 in the data tracking system 310 such that an operator trackingrecord or events profile 330 may be generated for each operator,monitoring both compliant events and non-compliant events.

With regard to system updates, each use of the portable test instrument102 by the operator can optionally cause the instrument to communicatewith the data tracking system 310 to update the operator tracking record330. This can include a sample test result being sent and stored in thetracking system 310. With regard to the attributes in the data trackingsystem 310, these may generally initially be set to a standard defaultsetting or template and the system manager may generally retain thedefault settings. However, the system manager may create new attributesand/or customize the settings of the attributes for a given medicalfacility. When a required attribute is updatable by the system manager325, the updated required attribute may be communicated to theinstrument 102 and displayed for the operator. In some embodiments, eachof the attributes may have a non-compliance or compliance threshold, anda combination of at least a certain number of (e.g., two) exceeded ornon-exceeded thresholds may be determinative of a lock out of theoperator from the instrument. In alternative embodiments, each of theattributes may have a non-compliance or compliance threshold, and astatistical combination of one or more exceeded or non-exceededthresholds may be determinative of lock out of the operator from theinstrument.

An advantage of the data tracking system 310 is that it mayautomatically track operator compliance for a plurality of operators.Furthermore, each portable test instrument 102 may be configured tocommunicate each sample test result and operator identity to the resultsstore 315 in the data tracking system 310. This may allow for the datatracking system 310 to generate an events profile 330 for each operator,including compliant events and non-compliant events. For example, anevents profile may include, in addition to the operator's identity, aset of event records for evaluations performed for that operator withrespect to each attribute, e.g., each of the College of AmericanPathologists' competency requirements, including where applicable thedate and time performed, the name of the evaluator, the elements orskills evaluated, and the assessment of competency level or compliance.Note also that the results store 315 may further comprise a store forknowledge tests, quality control tests, and/or proficiency testsperformed by the operator using the instrument or remote device.Therefore, some embodiments of the present invention may be implementedfor portable test instruments that perform tests on a blood samplecontained in a single-use cartridge, which mates with the instrument,generally where the cartridge contains electrochemical sensors oroptical assays (as described above with reference to FIG. 1).

Instrument and Cartridge Operator Competency and Compliance MonitoringMethod

FIGS. 5 and 6 show exemplary flowcharts for performing the process stepsof the present invention. The steps of FIGS. 5 and 6 may be implementedusing the computing device described above with respect to FIGS. 1-4.Specifically, the flowcharts in FIGS. 5 and 6 illustrate thearchitecture, functionality, and operation of possible implementationsof the systems, methods and computer program products according toseveral embodiments of the present invention. In this regard, each blockin the flowcharts may represent a module, segment, or portion of code,which comprises one or more executable instructions for implementing thespecified logical function(s). It should also be noted that, in somealternative implementations, the functions noted in the blocks may occurout of the order noted in the figure. For example, two blocks shown insuccession may, in fact, be executed substantially concurrently, or theblocks may sometimes be executed in the reverse order, depending uponthe functionality involved. It will also be noted that each block of theflowchart illustrations, and combinations of blocks in the flowchartillustrations, can be implemented by special purpose hardware-basedsystems that perform the specified functions or acts, or combinations ofspecial purpose hardware and computer instructions.

In one embodiment of the present invention, the computing device may beconfigured to assess the competency of an operator to operate at leastone sample testing instrument. As shown in FIG. 5, a process 500 may beprovided for compliance monitoring. At step 505, a plurality ofattributes may be generated to assess a competency level of the operatorto operate the at least one sample testing instrument. For example, thequality compliance manager may select predetermined attributes providedby a service provider to implement initial training and/or ongoingassessment of an operator's testing competency on the at least onesample testing instrument. The operator may be a non-laboratorian (e.g.,a nurse or doctor) and the at least one sample testing instrument may bea reading apparatus (as discussed with reference to FIG. 1).

In alternative or additional embodiments, the quality compliance managermay generate or set their own attributes and/or customize, update, orset default templates of attributes. The new or customized attributesmay therefore be generated specific to each operator or group ofoperators (e.g., Intensive Care Unit nurses).

In some embodiments, generating the plurality of attributes may compriseselecting a number of attributes (e.g., selecting at least twoattributes). The number of attributes may comprise a knowledge test foroperation of the at least one instrument, a knowledge test forbiological sample acquisition and disposition with the at least oneinstrument, a knowledge test on biological sample testing regulations, apractical test on obtaining biological sample test results with the atleast one instrument, a practical test on quality control testing withthe at least one instrument, and/or a practical test on data entry anddata handling with the at least one instrument.

In additional embodiments, the number of attributes may comprise directobservation of routine patient test performance, including testingperformance and monitoring the recording of the results (e.g., this mayinclude recording all test results performed by the operator on a sampletesting instrument and monitoring the results for any instrumentreported errors). The plurality of attributes may also include thereview of intermediate test results, quality control results,proficiency testing results, and preventive maintenance records (e.g.,this may include recording all of these results performed by theoperator and monitoring the results for inaccuracies or errors). Theplurality of attributes may also include observation of performance ofinstrument maintenance and function checks (e.g., this may includerecording the results of knowledge tests for operation of the at leastone instrument and/or training sessions on the at least one instrument).The plurality of attributes may also include the assessment of problemsolving skills (e.g., this may include recording the results ofknowledge tests for biological sample acquisition and disposition withthe at least one instrument and knowledge tests on biological sampletesting regulations).

In accordance with some aspects of the present invention, the attributesmay comprise an electronic signature element. The electronic signaturemay be configured to provide an indication as to whether the user adoptsthe contents of the attributes, or the user who claims to have generatedthe attributes is the one who generated the attributes. For example, theelectronic signature may be configured to provide an indication that thequality compliance manager generated or approved the attributes.

In accordance with additional aspects of the present invention, theattributes may comprise an electronic log event element. The electroniclog event element may be configured to store related information. Forexample, the electronic log event element may be configured to store thecompliance status and competency level for the operator.

At step 510, a compliance threshold for each attribute of the pluralityof attributes may be set (e.g., a quality compliance manager may inputthresholds for each attribute based on Point of Care Testing Policiesestablished at a medical facility). In some embodiments, the compliancethreshold may be set as a predetermined score (e.g., 80 out of 100)required for passing a knowledge test. In alternative embodiments, thecompliance threshold may be set as a predetermined number of errors(e.g., 5 errors pertaining to an incorrect sample being used for aspecified device or cartridge) within a predetermined amount of time orpredetermined number of analytical tests run. In additional oralternative embodiments, the compliance thresholds may be provided by aservice provider or compliance regulatory organization (e.g., College ofAmerican Pathologists).

At step 515, an overall compliance threshold may be set for the at leastone sample testing instrument. For example, the quality compliancemanager may determine a level of sophistication or knowledge required tooperate the at least one sample testing instrument and set the overallcompliance threshold accordingly.

At step 520, operator derived data pertaining to the operators abilityto operate the at least one sample testing instrument may be obtained.In some embodiments, the operator derived data may include a number(e.g., two) of attribute test results obtained by the operator. Theattribute test results may include analytical test results, control testresults, proficiency test results, and/or knowledge or training testresults. In some embodiments, the analytical test results, the controltest results, and the proficiency test results may be communicated orprovided to the data manager via the at least one sample testinginstrument. In other words, the sample testing instrument maycommunicate or provide the analytical test results, the control testresults, and the proficiency test results upon the operator operatingthe sample testing instrument to perform testing analysis.

In additional or alternative embodiments, the knowledge or training testresults may be communicated or provided by the quality compliancemanager or a remote computing device such as a personal computercomprising an application configured to present the knowledge ortraining test to the operator. As should be understood by one ofordinary skill in the art, the aforementioned results may be provided tothe data manager using any sample testing instrument or computing devicein accordance with some aspects of the present invention.

In some embodiments, the test results (e.g., analytical test results,control test results, proficiency test results, and/or knowledge ortraining test results) may be linked to a corresponding operatoridentifier configured to identify the operator that performed or tookthe test. For example, the operator identifier may be embedded withinmetadata of the test results or saved together in a table format. Inthese embodiments, obtaining the operator derived data may also comprisereceiving the operator identifier.

Optionally, an event profile for the operator may be generated thatcomprises the test results and is linked to the operator identifier suchthat the event profile is specific to the operator. In some embodiments,the event profile may also comprise the determined compliance status ofthe operator for each attribute and the competency level of the operatorfor the at least one sample testing instrument.

In some embodiments, new operator derived data may be obtained and usedto continuously update the event profile including the compliance statusfor each attribute and the competency level of the operator for the atleast one sample testing instrument. The competency status and thecompetency level may comprise a preset limited duration or expirationsuch that the competency status and competency level of the operatorshould be reevaluated after expiration.

In accordance with some aspects of the present invention, the operatoridentifier may be a password, a alpha-numerical or numerical code, abiometric identifier, an RFID tag or a barcode.

At step 525, the operator derived data may be compared to the setcompliance threshold for each attribute of the plurality of attributes.For example, one of the attributes may be set as a knowledge test forbiological sample acquisition. The operator derived data obtained maycomprise results from the operator taking the knowledge test. Thoseresults may be compared to the set compliance threshold for theknowledge test (e.g., the operator may have obtained an 85% on theknowledge test and the compliance threshold may have been set at 80%;thus, the data manager or tracking system compares the two variables).

At step 530, a compliance status of the operator for each attributebased on the comparison of the operator derived data to the setcompliance thresholds may be determined. For example, if the knowledgetest result of an 85% is greater than the compliance threshold of 80%,then the data manager may determine that the operator is compliant forthat attribute. In some embodiments, if the analytical test resultscomprise a number of errors greater than the set compliance threshold,then the data manager may determine that the operator is non-compliantfor that an attribute pertaining to patient test performance.

In accordance with some aspects of the present invention, determiningthe compliance status of the operator may comprise determining whetherthe electronic signature element for each attribute is completed by anauthorized user (e.g., quality compliance manager). Additionally,determining the compliance status of the operator may comprise recordingthe compliance status and/or competency level of the operator in theelectronic log event element.

At step 535, an overall compliance status of the operator may begenerated based on the determined compliance status of the operator foreach attribute. For example, the data manager may review the determinedcompliance statuses for each attribute to determine an overall grade forthe operator. In some embodiments, the overall compliance status may begenerated based on a sum of all of the compliant or non-compliantstatuses determined for each attribute.

At step 540, the overall compliance status of the operator may becompared to the set overall compliance for the at least one sampletesting instrument. For example, the sum of all compliant ornon-compliant statuses may be compared to a threshold level of overallcompliance or non-compliance for the at least one sample testinginstrument.

At step 545, a competency level of the operator for the at least onesample testing instrument may be determined based on the comparison ofthe overall compliance status of the operator to the set overallcompliance threshold. For example, the competency level of the operatormay be determined to be compliant if the sum of all compliant statusesis greater than the threshold level of overall compliance for the atleast one sample testing instrument.

In some embodiments, the set overall compliance threshold may compriseany combination of at least a number (e.g., two) of attributes having anon-approved compliance status. Determining the competency level maycomprise determining the competency level of the operator to benon-compliant when the overall compliance status includes at least anumber of attributes having a non-approved compliance status, anddetermining the competency level of the operator to be compliant whenthe overall compliance status includes less than a number of attributeshaving a non-approved compliance status.

In alternative embodiments, the set overall compliance threshold maycomprise any combination of at least a number (e.g., two) of attributeshaving an approved compliance status. Determining the competency levelmay comprise determining the competency level of the operator to becompliant when the overall compliance status includes at least a numberof attributes having an approved compliance status, and determining thecompetency level of the operator to be non-compliant when the overallcompliance status includes less than a number of attributes having anapproved compliance status.

In alternative embodiments, the set overall compliance threshold maycomprise a statistical combination of the plurality of attributes havingan approved compliance status and a non-approved compliance status.Determining the competency level may comprise determining the competencylevel of the operator to be compliant when the overall compliance statusis equal to or exceeds the statistical combination of the plurality ofattributes, and determining the competency level of the operator to benon-compliant when the overall compliance status is less than thestatistical combination of the plurality of attributes.

In alternative embodiments, the set overall compliance threshold maycomprise a statistical combination of the plurality of attributes havingan approved compliance status and a non-approved compliance status.Determining the competency level may comprise determining the competencylevel of the operator to be non-compliant when the overall compliancestatus is equal to or exceeds the statistical combination of theplurality of attributes, and determining the competency level of theoperator to be compliant when the overall compliance status is less thanthe statistical combination of the plurality of attributes.

At step 550, the determined competency level of the operator may becommunicated to the at least one sample testing instrument. For example,the data manager may send a competency level to at least one sampletesting instrument via the computer infrastructure.

As should be understood by one of ordinary skill in the art, one or moresteps in the process described in connection with FIG. 5 may occursimultaneously or substantially simultaneously with other process stepsand/or the order of the steps may be modified.

In one embodiment of the present invention, the biological sample testsystem may be configured to perform at least one analytical test on aninstrument and automatically lock out an operator from operating theinstrument based on the competency level of the operator. As shown inFIG. 6, a process 600 may be provided for generating operator deriveddata on an instrument and locking out a user from operating theinstrument. Optionally at step 605, the instrument may be configured toreceive input from an operator (e.g., an operator identifier), which maycomprise the operator derived data. At step 610, the instrument may beconfigured to generate the operator derived data. For example, theoperator may operate the instrument to analyze a biological sample onthe instrument, perform a proficiency test on the instrument, perform aknowledge test on the instrument, perform a control test on theinstrument, etc. In some embodiments, the instrument may be configuredto determine the result of the test(s) performed by the operator on theinstrument (e.g., an analytical test result), which may comprise theoperator derived data. In additional embodiments, any errors determinedby the instrument during the operation may also be determined asoperator derived data.

At step 615, the instrument may be configured to communicate theoperator derived data to the system infrastructure (e.g., the datamanger 104 as discussed with respect to FIG. 1). At step 620, theinstrument may be configured to receive the determined competency levelof the operator for the instrument(s). At step 625, the instrument maybe configured to lock out the operator from operating the instrument(s)if the competency level is non-compliant.

As should be understood by one of ordinary skill in the art, one or moresteps in the process described in connection with FIG. 6 may occursimultaneously or substantially simultaneously with other process stepsand/or the order of the steps may be modified.

In some embodiments, a service provider, such as the biological sampletest system provider, could offer to perform all or some of theprocesses described herein. In this case, the service provider cancreate, maintain, deploy, support, etc., the computer infrastructurethat performs the all or some of the process steps of the invention forone or more customers. These customers may be, for example, any businessthat uses the point of care technology. In return, the service providercan receive payment from the customer(s) under a subscription and/or feeagreement.

While the invention has been described in terms of various preferredembodiments, those skilled in the art will recognize that variousmodifications, substitutions, omissions and changes can be made withoutdeparting from the spirit of the present invention. It is intended thatthe scope of the present invention be limited solely by the scope of thefollowing claims. In addition, it should be appreciated by those skilledin the art that a plurality of the various embodiments of the invention,as described above, may be coupled with one another and incorporatedinto a single reader device.

We claim:
 1. A method implemented in a computer infrastructure havingcomputer executable code tangibly embodied on a computer readablestorage medium having programming instructions operable to: generate aplurality of attributes configured to assess a competency level of anoperator to operate at least one sample testing instrument operable toperform an analytical test; set a compliance threshold for the at leastone sample testing instrument; obtain operator derived data pertainingto the operator's ability to operate the at least one sample testinginstrument, wherein the operator derived data comprises at least twoattribute test results obtained by the operator; determine a compliancestatus of the operator for each of at least two attributes of theplurality of attributes based on a comparison of each of the obtained atleast two attribute test results to a set compliance status thresholdfor each of at least two attributes, respectively; determine an overallcompliance status of the operator based on the determined compliancestatus of the operator for each of the at least two attributes;determine the competency level of the operator for the at least onesample testing instrument based on a comparison of the overallcompliance status of the operator to the set compliance threshold; andcommunicate the competency level of the operator to the at least onesample testing instrument, wherein when the competency level of theoperator is indicative of non-compliance, the competency level causesthe at least one sample testing instrument to lock out the operator fromoperating the at least one sample testing instrument, wherein thegenerating the plurality of attributes comprises receiving a selectionof the at least two attributes from the group consisting of: a knowledgetest for operation of the at least one instrument, a knowledge test forbiological sample acquisition and disposition with the at least oneinstrument, a knowledge test on biological sample testing regulations, apractical test on obtaining biological sample test results with the atleast one instrument, a practical test on quality control testing withthe at least one instrument, a practical test on data entry and datahandling with the at least one instrument, wherein the at least oneinstrument comprises a disposable device, operating in conjunction witha hand-held analyzer, for performing the analytical test on blood orother fluids, and wherein the analytical test is at least one selectedfrom the group consisting of: oxygen, carbon dioxide, pH, potassium,sodium, chloride, hematocrit, glucose, urea, creatinine, prothrombintime (PT), activated clotting time (ACT), activated partialthromboplastin time (APTT), cardiac troponin I (cTnI), brain natriureticpeptide (BNP), creatine kinase MB (CKMB) and lactate.
 2. The method ofclaim 1, wherein: the at least two attribute test results are linked toa corresponding operator identifier configured to identify the operator;and the obtaining the operator derived data comprises receiving the atleast two attribute test results and the operator identifier.
 3. Themethod of claim 2, wherein: the at least two attribute test resultscomprise a knowledge test result obtained by the operator participatingin a knowledge test or training session; the knowledge test result islinked to the corresponding operator identifier configured to identifythe operator; and the obtaining the operator derived data furthercomprises receiving the knowledge test result and the operatoridentifier from at least one of the at least one sample testinginstrument and a computing device.
 4. The method of claim 3, wherein:the programming instructions are further operable to generate an eventprofile for the operator; the event profile comprises the at least twoattribute test results and the event profile is linked to the operatoridentifier configured to identify the operator; the event profilefurther comprises the compliance status of the operator for each of theat least two attributes and the competency level of the operator for theat least one instrument; the compliance status of the operator for eachof the at least two attributes comprises a preset limited duration; andthe programming instructions are further operable to receive newoperator derived data and continuously update the event profileincluding the compliance status of the operator for each of the at leasttwo attributes and the competency level of the operator based on thereceived new operator derived data.
 5. The method of claim 1, wherein:each attribute of the plurality of attributes comprises an electronicsignature element; and the determining the compliance status of theoperator for each of at least two attributes further comprisesdetermining whether the electronic signature element for each attributeis completed by an authorized user.
 6. The method of claim 5, wherein:each attribute of the plurality of attributes comprises an electroniclog event element; and the determining the compliance status of theoperator for each of the at least two attributes further comprisesrecording the compliance status of the operator for each of the at leasttwo attributes in the electronic log event element.
 7. The method ofclaim 1, wherein the generating the plurality of attributes comprisessetting each of the plurality of attributes to a default template. 8.The method of claim 1, wherein: the set compliance threshold comprisesany combination of the at least two attributes having a non-approvedcompliance status; and the determining the competency level comprises:when the overall compliance status includes the at least two attributeshaving a non-approved compliance status, determining the competencylevel to be non-compliant; and when the overall compliance statusincludes less than the at least two attributes having a non-approvedcompliance status, determining the competency level to be compliant. 9.The method of claim 1, wherein: the set compliance threshold comprisesany combination of the at least two attributes having an approvedcompliance status; and the determining the competency level comprises:when the overall compliance status includes the at least two attributeshaving an approved compliance status, determining the competency levelto be compliant; and when the overall compliance status includes lessthan the at least two attributes having a non-approved compliancestatus, determining the competency level to be non-compliant.
 10. Themethod of claim 1, wherein: the set compliance threshold comprises astatistical combination of the plurality of attributes having anapproved compliance status and a non-approved compliance status; and thedetermining the competency level comprises: when the compliance statusis equal to or exceeds the statistical combination of the plurality ofattributes, determining the competency level to be compliant; and whenthe compliance status is less than the statistical combination of theplurality of attributes, determining the competency level to benon-compliant.
 11. The method of claim 1, wherein: the set compliancethreshold comprises a statistical combination of the plurality ofattributes having an approved compliance status and a non-approvedcompliance status; and the determining the competency level comprises:when the compliance status is equal to or exceeds the statisticalcombination of the plurality of attributes, determining the competencylevel to be non-compliant; and when the compliance status is less thanthe statistical combination of the plurality of attributes, determiningthe competency level to be compliant.
 12. The method of claim 1, whereina service provider at least one of creates, maintains, deploys andsupports the computer infrastructure.
 13. The method of claim 1, whereinsteps of claim 1 are provided by a service provider on a subscriptionand/or fee basis.
 14. A system implemented in hardware, comprising: atracking module configured to: generate a plurality of attributesconfigured to assess a competency level of an operator to operate atleast one sample testing instrument operable to perform an analyticaltest; set a compliance threshold for the at least one sample testinginstrument; obtain operator derived data pertaining to the operator'sability to operate the at least one sample testing instrument, whereinthe operator derived data comprises at least two attribute test resultsobtained by the operator; determine a compliance status of the operatorfor each of at least two attributes of the plurality of attributes basedon a comparison of each of the obtained at least two attribute testresults to a set compliance status threshold for each of at least twoattributes, respectively; determine an overall compliance status of theoperator based on the determined compliance status of the operator foreach of the at least two attributes; determine the competency level ofthe operator for the at least one sample testing instrument based on acomparison of the overall compliance status of the operator to the setcompliance threshold; and communicate the competency level of theoperator to the at least one sample testing instrument, wherein when thecompetency level of the operator is indicative of non-compliance, thecompetency level causes the at least one sample testing instrument tolock out the operator from operating the at least one sample testinginstrument, wherein the generating the plurality of attributes comprisesreceiving a selection of the at least two attributes from the groupconsisting of: a knowledge test for operation of the at least oneinstrument, a knowledge test for biological sample acquisition anddisposition with the at least one instrument, a knowledge test onbiological sample testing regulations, a practical test on obtainingbiological sample test results with the at least one instrument, apractical test on quality control testing with the at least oneinstrument, a practical test on data entry and data handling with the atleast one instrument, wherein the at least one instrument comprises adisposable device, operating in conjunction with a hand-held analyzer,for performing the analytical test on blood or other fluids, and whereinthe analytical test is at least one selected from the group consistingof: oxygen, carbon dioxide, pH, potassium, sodium, chloride, hematocrit,glucose, urea, creatinine, calcium, prothrombin time (PT), activatedclotting time (ACT), activated partial thromboplastin time (APTT),cardiac troponin I (cTnI), brain natriuretic peptide (BNP), creatinekinase MB (CKMB) and lactate.
 15. The system of claim 14, wherein: theat least two attribute test results are linked to a correspondingoperator identifier configured to identify the operator; and theobtaining the operator derived data comprises receiving the at least twotest attribute results and the operator identifier.
 16. The system ofclaim 15, wherein: the at least two attribute test results comprise aknowledge test result obtained by the operator participating in aknowledge test or training session; the knowledge test result is linkedto the corresponding operator identifier configured to identify theoperator; and the obtaining the operator derived data further comprisesreceiving the knowledge test result and the operator identifier from atleast one of the at least one sample testing instrument and a computingdevice.
 17. The system of claim 16, wherein: the tracking module isfurther configured to generate an event profile for the operator; andthe event profile comprises the at least two attribute test results andthe event profile is linked to the operator identifier configured toidentify the operator.
 18. A computer program product comprising anon-transitory computer readable storage medium having readable programcode embodied in the storage medium, the computer program productincludes at least one component operable to: generate a plurality ofattributes configured to assess a competency level of an operator tooperate at least one sample testing instrument operable to perform ananalytical test; set a compliance threshold for the at least one sampletesting instrument; obtain operator derived data pertaining to theoperator's ability to operate the at least one sample testinginstrument, wherein the operator derived data comprises at least twoattribute test results obtained by the operator; determine a compliancestatus of the operator for each of at least two attributes of theplurality of attributes based on a comparison of each of the obtained atleast two attribute test results to a set compliance status thresholdfor each of at least two attributes, respectively; determine an overallcompliance status of the operator based on the determined compliancestatus of the operator for each of the at least two attributes;determine the competency level of the operator for the at least onesample testing instrument based on a comparison of the overallcompliance status of the operator to the set compliance threshold; andcommunicate the competency level of the operator to the at least onesample testing instrument, wherein when the competency level of theoperator is indicative of non-compliance, the competency level causesthe at least one sample testing instrument to lock out the operator fromoperating the at least one sample testing instrument, wherein thegenerating the plurality of attributes comprises receiving a selectionof the at least two attributes from the group consisting of: a knowledgetest for operation of the at least one instrument, a knowledge test forbiological sample acquisition and disposition with the at least oneinstrument, a knowledge test on biological sample testing regulations, apractical test on obtaining biological sample test results with the atleast one instrument, a practical test on quality control testing withthe at least one instrument, a practical test on data entry and datahandling with the at least one instrument, wherein the at least oneinstrument comprises a disposable device, operating in conjunction witha hand-held analyzer, for performing the analytical test on blood orother fluids, and wherein the analytical test is at least one selectedfrom the group consisting of: oxygen, carbon dioxide, pH, potassium,sodium, chloride, hematocrit, glucose, urea, creatinine, calcium,prothrombin time (PT), activated clotting time (ACT), activated partialthromboplastin time (APTT), cardiac troponin I (cTnI), brain natriureticpeptide (BNP), creatine kinase MB (CKMB) and lactate.